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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Gas, Anesthetic
510(k) Number K903881
Device Name VENTLAB VENT-MASK, CAT# VR 0010/20/30
Applicant
Ventlab Corp.
221 Gracie Pl.
Hackensack,  NJ  07601
Applicant Contact GREGORY LAU
Correspondent
Ventlab Corp.
221 Gracie Pl.
Hackensack,  NJ  07601
Correspondent Contact GREGORY LAU
Regulation Number868.5550
Classification Product Code
BSJ  
Date Received08/22/1990
Decision Date 09/04/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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